Informed Consent – Instructions

Informed consent is an integral part of research. It has as legal, regulatory, and ethicalaspects. It is based on respect for the individual, and his autonomy or capacity and rightto make choices. It is a process that involves conveying accurate and relevantinformation about the study and its purpose; disclosing known risks, benefits,alternatives, and procedures; answering questions; and enabling the potential participantto make an informed decision about whether to participate or not.

An informed consent should include the following items. Please develop the consent form under each numbered section:

  1. Purpose of the study/research

A high-level statement indicating the main purpose of the study.

  1. Known potential risks and discomforts to the participant

Any risk or discomfort to the subject that is likely to occur as a result of the study should be clearly described.

  1. Potential benefits to the participant and/or others

All potential benefits of the study should be clearly stated to the participant.

  1. Confidentiality protection for the participant

Procedures describing how confidentiality of private informationis maintained should be included. This applies to all forms of information, including electronic forms.

  1. Procedure

Procedure that the participants would be expected to undergo should be described in sufficient interview time, duration, what will be collected, … etc. Any procedures that are experimental/ investigational/ non-therapeutic should be clearly identified.

  1. Alternative procedures

Alternate procedure for those who refuse to join should be mentioned clearly. Those participants who refuse to join the study should not be denied access to alternate procedure of their free choice nor suffer negative consequences of their lack of participation.

  1. Time frame and Compensation

The amount of time the participant is involved in the study should be indicated. Compensation to be provided to the participants for their voluntarily participation in the research must be indicated. The compensation must not be so excessive and should not appear to exert an undue influence on the participant.

  1. Financial liability

Financial liability and source of funding should be clearly described. Participants should not bear any financial burden or cost of management of injuries as a result of participating in the study. Management of such injuries should be covered by the funding agencies, or arrangement should be made to manage such injuries or side effects free of cost to the study subjects.

  1. Right to withdraw without penalty

Participants should have a right to withdraw from the study any time without any penalty or loss of benefits, which s/he is otherwise entitled to.

  1. Contact information for questions regarding the study

Name and contact numbers of the researcher and/or study supervisor should be given so that the subject may contact him/her in case s/he has any question to ask or report any side effect or injury suspected to happen as a result of his/her participation in the study.

  1. Consent

Participant’s signature is needed and indicates that he or she have decided to volunteer as a research participant for this study, and that he or she have read and understood the information provided above. The participant will be given a signed and dated copy of this form to keep, along with any other printed materials deemed necessary by the study investigators

General criteria for assessing an informed consent

  1. Language

The information should be provided in a language which the participant is able to understand and comprehend easily. Additionally, the writing should be easy to understandby common people, having primary education. Avoid technical terms.

  1. Competency of study subjects

The participant must be competent to make decision to participate or not toparticipate in the study. If the participant is not competent due to his/her age,illness, incapacity, or any other reason, either the participant should not beincluded in the research or some other provisions apply, such asthe guardian’s or parentalconsent etc.

  1. Dealing with children and the mentally incapacitated

In case of minors, their parental / guardian’s consent and minor’s accent must be obtained. In case of mentally impaired or incapacitated subjects, temporarily or permanently, their next of kin’s or guardian’s consent must be obtained. If the participant gains enough mental capacity to understand and comprehend, his consent should be obtained. If he declines the consent, he should be withdrawn from the study.

  1. Comprehension

Due consideration should be given to potential participant’s ability to understandthe proposed intervention in the study.

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ISC-ERC Informed Consent Instructions | Version 1.0 – Updated 18 September 2018

Ethics Review Committee – Information Science Department

College of Computing Sciences and Engineering, Kuwait University